UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Acronym	A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function.
Scientific Title	A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Scientific Title:Acronym	A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of 4-week intake of lactic acid bacteria containing foods on improvement of bowel movement and immune function in healthy volunteers with a tendency to be constipated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency, feeling after defecation, ease of defecation, amount, smell and color of feces, fecal condition (Measure at a daily basis for 1 week during the pre-treatment period, and in the week right before the 2nd, 4th and 6th week when the treatment started) Activity of NK cell and concentration of IgA in blood (Measure at before ingestion and after 4-week intake)
Key secondary outcomes	Adverse event(Inquiry consultation) Blood lipid maker (Measure at before ingestion and after 4-week intake)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Pre-treatment observation period(1 week), treatment observation period, subject take the test food(4 weeks), post-treatment observation period(2 weeks)
Interventions/Control_2	Pre-treatment observation period(1 week), treatment observation period, subject take the placebo food(4 weeks), post-treatment observation period(2 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Males and females, aged 20 - 65 years old with constipation tendency with defecation frequency 5 times or less per week. 2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1) Subjects who have medical history of malignant tumor, heart failure or myocardial infarction. 2) Subject receiving treatment for gastrointestinal diseases and constipation disease. 3) Currently undergoing treatment for or having a medical history with any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4) Subjects who frequently take medicines for intestinal disorder or laxatives 5) Subjects who frequently take medicines (including herbal medicines) 6) Subjects who are allergic to medicines and/or the test food related products. 7) Subjects with irregular life rhythms such as shift workers, irregular eating habits. 8) Subjects who are pregnant, breast-feeding, or planning to get pregnant. 9) Subjects who have been enrolled in other clinical trials. 10) Subjects who are considered as ineligible to participate in the study by the physician.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development department
Zip code	615-8245
Address	1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	0753948605
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Ishida
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development department
Zip code	615-8245
Address	1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	0753948605
Homepage URL
Email	a-ishida@pharmafoods.co.jp

Sponsor
Institute	Other Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization	Self-funding None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Pharma Foods International Research Ethics Committee
Address	1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
Tel	0753948600
Email	m-aosasa@pharmafoods.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 04 Month 03 Day
Date of IRB	2019 Year 04 Month 10 Day
Anticipated trial start date	2019 Year 07 Month 30 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 29 Day
Last modified on	2020 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042785